An interventional study of Dual-energy X-ray absorptiometry and Vertebral fracture analysis in Sickle Cell Disease, Sickle Cell Anemia and Low Bone Density, sponsored by University of California, Davis. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by University of California, Davis · Not applicable, Interventional, and Screening
Among 733 studies in Anemia, Sickle Cell with a site in United States — 135 open to participants now, 186 under way, 16 of them phase 3. Anemia, Sickle Cell · United States.
Among the 733 studies in Anemia, Sickle Cell with a site in United States, this one is the 186th largest by enrollment of the 559 interventional ones, is one of 41 that started in 2022, is one of 165 with no phase, reaches primary completion later than 9 of the 182 other live ones, and was the 581st registered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's enrollment of 53 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →135 of the 733 studies in Anemia, Sickle Cell with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →733 studies; the count open now beside each. This study's row is marked.
First in 1984; this study’s year is marked. 41 started in 2022.
Median enrollment 31 across the 559 interventional studies, 100 across the 168 observational. Of the 506 that completed or were terminated, 207 (41%) have results posted.
168 of 733 have an industry lead sponsor. The 10 most frequent:
University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
University of California, Davis has 2 studies filed under Anemia, Sickle Cell — fewer than ten, so there is no comparison to draw.
57 of the studies in Anemia, Sickle Cell with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07247188Phase 3SanofiStudy of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease | 2027-01-07 |
| NCT04293185Phase 3bluebird bioA Study Evaluating Gene Therapy With BB305 Lentiviral Vector in Sickle Cell Disease | 2027-05 |
| NCT06989567Phase 3Asklepion Pharmaceuticals, LLCA Study of Intravenous L-Citrulline in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting to Emergency Departments in Acute Vaso-Occlusive Crisis | 2027-06 |
| NCT05329649Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD) | 2027-06-06 |
| NCT05477563Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease | 2027-06-09 |
Among the 733 studies in Anemia, Sickle Cell with a site in United States, from their registry updates:
A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease
The investigators hypothesize that adults with sickle cell disease (SCD) and low bone density and/or vertebral compression fractures on a dual X-ray absorptiometry (DXA) scan (adjusted for age, sex, SCD genotype, relevant labs, presence of osteonecrosis, and SCD-modifying therapies) will report more severe pain than those with normal bone density or no vertebral fractures. The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) is a validated patient-reported outcome measure of physical, mental, and social health in adults with SCD. This cross-sectional observational study involves obtaining a baseline DXA scan, vertebral fracture analysis (VFA) and pain assessment using ASCQ-Me pain impact scores. The investigators plan to recruit 50 adults with SCD followed at University of California Davis Medical Center between Nov 2022- Dec 2023 and anticipate enrolling up to 4 adults with SCD per month. The study endpoints are listed below:
The investigators' goal is to complete primary data analysis by Mar 2024. As an exploratory endpoint, 1cc of serum and 5cc of urine will be collected from each study participant once (at baseline), after an overnight fast, for bone biomarker analyses.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective cohort of 50 adults with sickle cell disease (SCD) undergoing research DXA scan to assess bone mineral density and thoracolumbar morphometry for vertebral fracture analysis
Other: Dual-energy X-ray absorptiometry · Other: Vertebral fracture analysis · Other: Adult Sickle Cell Quality of Life Measurement System pain impact questionnaire
Measure bone mineral density at the lumbar spine, left total hip, left forearm, and whole body
Also known as: DXA scan
Obtain thoracolumbar morphometry in DXA scan, then determine presence and severity of vertebral compression fractures by VFA
Also known as: VFA
Calculate patient-reported total pain scores to determine the pain phenotype of each study participant
Also known as: ASCQ-Me Pain scores
Lumbar Spine Bone Mineral Density
Areal bone mineral density of the lumbar spine measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.
Time frame: Baseline
Lumbar Spine Bone Mineral Density-Z-scores
Number of standard deviations between measured lumbar spine bone mineral density (g/cm2) for each participant and mean lumbar spine bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.
Time frame: Baseline
Total Hip Bone Mineral Density (BMD)
Areal bone mineral density of the total hip measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.
Time frame: Baseline
Total Hip Bone Mineral Density-Z-scores
Number of standard deviations between measured total hip bone mineral density (g/cm2) for each participant and mean total hip bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.
Time frame: At enrollment
Femoral Neck Bone Mineral Density (BMD)
Areal bone mineral density of the femoral neck measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.
Time frame: Baseline
Femoral Neck Bone Mineral Density Z-scores
Number of standard deviations between measured lumbar spine bone mineral density (g/cm2) for each participant and mean lumbar spine bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.
Time frame: Baseline
Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact T-scores
Patient-reported outcome measure of pain impact in the preceding 7 days before bone density measurements. The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) pain impact T-scores range from about 30-100. The ASCQ-Me pain impact T-score has standardized mean T-score of 50 and standard deviation of 10, which were derived from a reference population of ambulatory adult with sickle cell disease across the United States. ASCQ-Me pain impact T-scores less than 50 are lower/worse than the reference mean (more severe pain impact), while pain impact T-scores greater than 50 are above/better than the reference mean (less severe pain impact)
Time frame: Baseline
Spinal Deformity Index
The spinal deformity index (SDI) is a semi-quantitative measure of number and severity of vertebral fractures observed on lateral spine X-rays of the thoracolumbar spine. To calculate the SDI, vertebrae are assigned a score as follows: 0 (no fracture), 1 (mild fracture), 2 (moderate fracture), and 3 (severe fracture). The total SDI is the summation of all T12-L4 vertebrae measured on the lateral spine X-rays. Minimum SDI =0 and Maximum SDI=15. Higher scores mean increased (worse) fracture burden, lower scores mean decreased (less) fracture burden.
Time frame: Baseline
One hundred and twenty-eight unique adults (age 18 years and older) with SCD of any genotype seen in the Adult Sickle Cell clinic at UCD's Comprehensive Cancer Center between 2022-2023 were eligible to participate in the SCD Bone Pain study.
| Milestone | SCD Bone Pain Study Cohort |
|---|---|
| Started | 53 |
| Completed | 53 |
| Not completed | 0 |
Areal bone mineral density of the lumbar spine measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.
| g/cm2 | Group A | Group B |
|---|---|---|
| Lumbar Spine Bone Mineral Density | 0.97 (0.62 to 1.31) | 1.0 (0.72 to 1.67) |
Number of standard deviations between measured lumbar spine bone mineral density (g/cm2) for each participant and mean lumbar spine bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.
| Z-score | Group A | Group B |
|---|---|---|
| Lumbar Spine Bone Mineral Density-Z-scores | -1.35 (-4.40 to 1.60) | -1.60 (-4.30 to 4.30) |
Areal bone mineral density of the total hip measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.
| g/cm2 | Group A | Group B |
|---|---|---|
| Total Hip Bone Mineral Density (BMD) | 0.90 (0.66 to 1.34) | 1.03 (0.67 to 1.76) |
Number of standard deviations between measured total hip bone mineral density (g/cm2) for each participant and mean total hip bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.
| Z-score | Group A | Group B |
|---|---|---|
| Total Hip Bone Mineral Density-Z-scores | -0.75 (-2.30 to 2.00) | -0.5 (-2.7 to 3.5) |
Areal bone mineral density of the femoral neck measured by dual-energy X-ray absorptiometry (DXA) scan and reported in grams per square centimeter.
| g/cm2 | Group A | Group B |
|---|---|---|
| Femoral Neck Bone Mineral Density (BMD) | 0.77 (0.53 to 1.30) | 0.94 (0.63 to 1.68) |
Number of standard deviations between measured lumbar spine bone mineral density (g/cm2) for each participant and mean lumbar spine bone mineral density (g/cm2) of the reference population. A Z-score of 0 represents the mean of the reference population. A negative Z-score means the measured bone mineral density values are lower (worse) the reference mean, while positive Z-scores mean they are above/higher. Bone mineral density Z-scores ≤ -2 indicates low bone density.
| Z-score | Group A | Group B |
|---|---|---|
| Femoral Neck Bone Mineral Density Z-scores | -0.95 (-2.7 to 2.4) | -0.60 (-2.3 to 4.0) |
Patient-reported outcome measure of pain impact in the preceding 7 days before bone density measurements. The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) pain impact T-scores range from about 30-100. The ASCQ-Me pain impact T-score has standardized mean T-score of 50 and standard deviation of 10, which were derived from a reference population of ambulatory adult with sickle cell disease across the United States. ASCQ-Me pain impact T-scores less than 50 are lower/worse than the reference mean (more severe pain impact), while pain impact T-scores greater than 50 are above/better than the reference mean (less severe pain impact)
| T-score | Group A | Group B |
|---|---|---|
| Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact T-scores | 47.1 (42.4 to 52.8) | 52.4 (45.3 to 56.5) |
The spinal deformity index (SDI) is a semi-quantitative measure of number and severity of vertebral fractures observed on lateral spine X-rays of the thoracolumbar spine. To calculate the SDI, vertebrae are assigned a score as follows: 0 (no fracture), 1 (mild fracture), 2 (moderate fracture), and 3 (severe fracture). The total SDI is the summation of all T12-L4 vertebrae measured on the lateral spine X-rays. Minimum SDI =0 and Maximum SDI=15. Higher scores mean increased (worse) fracture burden, lower scores mean decreased (less) fracture burden.
| score on a scale | Group A | Group B |
|---|---|---|
| Spinal Deformity Index | 2.00 ± 2.71 | 3.13 ± 3.98 |
Collected over 13 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SCD Bone Pain Study Cohort | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Continuous(Years) | SCD Bone Pain Study Cohort |
|---|---|
| Median | 36 (20 to 67) |
| Sex: Female, Male(Participants) | SCD Bone Pain Study Cohort |
|---|---|
| Female | 34 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | SCD Bone Pain Study Cohort |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 51 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | SCD Bone Pain Study Cohort |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 50 |
| White | 1 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | SCD Bone Pain Study Cohort |
|---|---|
| United States | 53 |
| Height(cm) | SCD Bone Pain Study Cohort |
|---|---|
| Median | 172 (152 to 194) |
| Body mass index (BMI)(kg/m2) | SCD Bone Pain Study Cohort |
|---|---|
| Median | 24.6 (18.7 to 39.9) |
| Sickle cell disease (SCD) genotype(Participants) | SCD Bone Pain Study Cohort |
|---|---|
| Hb SS | 30 |
| Hb SC | 15 |
| Hb SB0 | 5 |
| Hb SB+ | 2 |
| Hb SD | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2022 to primary completion in Apr 2024, 17 months.
Results were first posted in Aug 2025, 1 year 3 months after primary completion.
Of 165 non-industry interventional studies with no phase under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's 17 months is below that.
Counting every sponsor, half of 173 studies reached it within 28 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Davis →